Brief Summary from the Circulatory System Devices Panel Meeting - January 13, 2005

A meeting of the Circulatory System Devices Panel was held on January 13, 2005, at the Hilton Hotel located at 620 Perry Parkway in Gaithersburg, Maryland. The meeting opened with a presentation by Binita Ashar, MD, MBA, Acting Clinical Deputy Director, CDRH, describing the FDA’s “Critical Path” Initiative. Megan Moynahan, Branch Chief of the Pacing, Defibrillator and Leads Branch of the Division of Cardiovascular Devices presented an update to the panel regarding two devices brought before this panel on July 28 and 29, 2004. Ms. Moynahan discussed the September 14, 2004 approval of the Guidant COMPANION study labeling change and the September 16, 2004 clearance of the Phillips Medical HeartStart Home Over-The-Counter Automated External Defibrillator.

The Panel discussed, made recommendations, and voted on a premarket approval application (P040043) for the Gore TAG Thoracic Endoprosthesis. The Gore TAG Thoracic Endoprosthesis is intended for endovascular repair of the descending thoracic aorta.

Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the PMA was recommended for “approval with conditions” by an 8 to 2 vote with 1 abstention. Among the conditions of approval was a post-market study that would enroll a predetermined number of patients to be followed for 5 years with specific endpoints recommended during the panel discussion, a physician training program, and labeling modifications to include inclusion/exclusion criteria from the pivotal trial in the Indications for Use for the device.